A Real-world Study Comparing the Effectiveness of Ofatumumab and Ocrelizumab Treatment in Multipl… (NCT07566988) | Clinical Trial Compass
CompletedNot Applicable
A Real-world Study Comparing the Effectiveness of Ofatumumab and Ocrelizumab Treatment in Multiple Sclerosis Patients
United States2,604 participantsStarted 2024-10-25
Plain-language summary
The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
Pooled OMB and OCR Cohorts:
* ≥1 incident claim for OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) in the patient identification period (index date = first claim date).
* No claims for OMB or OCR within the 12 months prior to the index date.
* ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with a diagnosis of MS in the first position in the 12 months prior to or on index date.
* ≥18 years of age on index date.
* Continuous healthcare plan enrollment for ≥12 months prior to index date (baseline period) and ≥6 months after index date (follow-up period).
* Persistent use of OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) for ≥6 months after index date.
Treatment-naïve OMB and OCR Cohorts:
* Included in Pooled OMB Cohort or Pooled OCR Cohort.
* No claims for a disease modifying therapy (DMT) used for the treatment of MS within the 12-month baseline period.
Exclusion criteria:
• None.
What they're measuring
1
Annualized Relapse Rate (ARR) in Treatment-Naïve Patients
Timeframe: Up to approximately 3 years and 11 months